Alzheimer's Disease
Conditions
Brief summary
This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.
Interventions
DRUGMABT5102A
Repeating subcutaneous injection
DRUGplacebo
Repeating subcutaneous injection
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria * Mini-Mental State Examination (MMSE) score of 18-26 points at screening * Geriatric Depression Scale (GDS-15) score of \< 6 * Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders) * For patients currently receiving treatment with approved AD treatments (AChE inhibitors or memantine): Treatment initiated and continued for at least the last 3 months prior to randomization, at a stable dose for at least the last 2 months prior to randomization
Exclusion criteria
* Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care * History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation) * History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion) * Hospitalization within 4 weeks prior to screening * Previous treatment with MABT5102A or any other therapeutic that targets Abeta * Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in brain amyloid load as assessed by amyloid PET imaging | Baseline to Week 69 |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease | Baseline to Week 69 |
| Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging | Baseline to Week 69 |
| Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score | Baseline to Week 73 |
Countries
France, Spain, United States
Outcome results
None listed